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Understanding how drugs work has never been easy.
Since 2000, the U.S. Food and Drug Administration has reported a general decrease in the number of new molecular entities -- drugs with new chemical structures -- submitted for approval each year, indicating a decline in the discovery of new drugs. Thirty-six years ago, pharmaceutical professionals also worried about drug discovery and lamented a decline in the rate at which new drugs were reaching the U.S. market. In December 1970, Technology Review published "Drugs: Has the Age of -Miracles Passed?...and Will That of -Science Ever Dawn?" It was a two-part review of a symposium on drug discovery at the American Chemical Society's national meeting that year. Barry M. Bloom, a representative from Pfizer, presented data, summarized in the bar graph shown here, demonstrating a decline in the rate of drug discovery.
In 1962 the Food, Drug and Cosmetic Act was amended to require that any new drug should be not only safe but efficacious. Since 1962, Mr. Bloom finds, there has been a marked tendency for new drugs to be either antibiotics, cancer treatments, or neural agents, to the neglect of the general run of diseases. In his view, discovery goes on very much as it used to, but the only drugs that reach the U.S. market are those for which an efficacy demonstration is relatively easy.
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